EP1455881A1 - Guide wire with adjustable flexibility - Google Patents
Guide wire with adjustable flexibilityInfo
- Publication number
- EP1455881A1 EP1455881A1 EP02776024A EP02776024A EP1455881A1 EP 1455881 A1 EP1455881 A1 EP 1455881A1 EP 02776024 A EP02776024 A EP 02776024A EP 02776024 A EP02776024 A EP 02776024A EP 1455881 A1 EP1455881 A1 EP 1455881A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- guide wire
- variable stiffness
- flexibility
- polymeric member
- heat source
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 210000005166 vasculature Anatomy 0.000 claims abstract description 10
- 230000009477 glass transition Effects 0.000 claims description 12
- 238000010438 heat treatment Methods 0.000 claims description 12
- 229920000431 shape-memory polymer Polymers 0.000 claims description 12
- 230000008859 change Effects 0.000 claims description 7
- 230000003213 activating effect Effects 0.000 claims description 5
- 230000004913 activation Effects 0.000 claims description 5
- 239000000155 melt Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 claims 8
- 230000008878 coupling Effects 0.000 description 7
- 238000010168 coupling process Methods 0.000 description 7
- 238000005859 coupling reaction Methods 0.000 description 7
- 229920000642 polymer Polymers 0.000 description 6
- 230000036760 body temperature Effects 0.000 description 5
- 229910001000 nickel titanium Inorganic materials 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 3
- -1 MP35N Inorganic materials 0.000 description 2
- 239000004020 conductor Substances 0.000 description 2
- 229910001026 inconel Inorganic materials 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 229910000851 Alloy steel Inorganic materials 0.000 description 1
- 229910001080 W alloy Inorganic materials 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000009849 deactivation Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/0915—Guide wires having features for changing the stiffness
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Definitions
- the present invention generally relates to intravascular guide wires.
- the present invention relates to intravascular guide wires having adjustable flexibility.
- Intravascular guide wires are often used to facilitate the delivery of therapeutic and diagnostic devices to remote vascular sites in the human body.
- intravascular guide wires are used to navigate through a patient's vasculature from a convenient location outside the patient's body, to a target site inside the patient's body requiring diagnosis and/or therapy. Once access to the target site has been provided by the guide wire, a therapeutic or diagnostic device (e.g., catheter) may then be advanced over the guide wire to the target site, and the desired therapeutic or diagnostic steps may be performed.
- a therapeutic or diagnostic device e.g., catheter
- the guide wire To facilitate navigation in tortuous vasculature, it is desirable that the guide wire have a relatively flexible distal end. To provide good support for devices advanced over the guide wire, it is desirable that the guide wire have a relatively stiff distal end. Conventional guide wires typically address these competing needs by establishing a compromise in flexibility and stiffness. However, it would be desirable to have a guide wire that does not compromise these competing needs.
- the present invention provides, in one exemplary embodiment, a guide wire that has a distal portion with adjustable flexibility.
- the guide wire includes a distal polymeric member and a heat source.
- the heat source may be activated by a power supply, which causes the polymeric member to increase in temperature, to thereby increase the flexibility of the distal portion of the guide wire.
- the polymeric member may comprise a shape memory polymer having a glass transition temperature, wherein the increase in temperature is across the glass transition temperature.
- the increase in flexibility of the distal portion of the guide wire enhances the ability of the guide wire to navigate vasculature of varying degrees of tortuosity.
- the heat source may be deactivated, which causes the polymeric member to decrease in temperature, to thereby increase the stiffness of the distal portion of the guide wire and provide enhanced support for devices advanced thereon.
- Figure 1 is a plan view of a guide wire system, including a guide wire, a controller/power source and a coupling/lead therebetween, in accordance with an exemplary embodiment of the present invention
- Figure 2 is a longitudinal cross-sectional view taken along line 2 - 2 in Figure
- the guide wire system includes a guide wire 10 connected to a controller and power source 50 by a coupling 40 and lead 60.
- Guide wire 10 includes an elongate shaft 12 having a proximal portion 14 and a distal portion 16.
- Distal portion 16 includes a soft atraumatic tip 18.
- the proximal portion 14 of the shaft 12 is relatively stiff to provide pushability and torquability, and the distal portion 16 has adjustable flexibility to provide trackability in navigating tortuous vasculature and support for devices advanced thereover.
- the guide wire 10 may have conventional dimensions and may be formed of conventional materials using conventional techniques known for intravascular guide wires used to navigate the human vasculature to remote locations including, but not limited to, the neurovasculature, the coronary vasculature, and the peripheral vasculature.
- the distal portion 16 of the guide wire 10 includes a heat source that is thermally connected to a polymeric member that increases in flexibility when heated, and increases in stiffness (e.g., returns to its nominal flexibility or stiffness at body temperature) when cooled.
- a heat source that is thermally connected to a polymeric member that increases in flexibility when heated, and increases in stiffness (e.g., returns to its nominal flexibility or stiffness at body temperature) when cooled.
- the flexibility of the polymeric member, and thus the flexibility of the distal portion 16 may be adjusted.
- the flexibility of the distal portion 16 may be increased by activating the heat source, which enhances the ability of the guide wire 10 to navigate tortuous vasculature to a target site.
- the heat source may be deactivated to cause the distal portion 16 to increase in stiffness, which enhances guide wire 10 support provided for devices (e.g., catheters) advanced thereon.
- a controller/power supply 50 is connected by lead 60 to a coupling 40 which is releasably and rotatably connected to the proximal portion 14 of the guide wire shaft 12.
- Controller/power supply 50 may comprise a conventional power supply with conventional control circuitry to provide a constant or modulated AC or DC signal.
- the signal is transmitted by lead 60, which may comprise two (or more) conductors.
- the conductors in the lead 60 may be connected to leads in the shaft 12 of the guide wire by coupling 40.
- Coupling 40 may be removable to permit devices such as catheters to be advanced over the proximal end of the guide wire 10.
- Coupling 40 may also be rotatable to permit the guide wire to be rotated and steered during intravascular navigation.
- the shaft 12 includes a hypotube 22 which may comprise, for example, stainless steel or a super elastic metal such as a nickel titanium alloy, Nitinol, MP35N, Inconel, etc.
- the hypotube 22 may extend from the proximal end of the guide wire shaft 12, and may include an outer sleeve 24 comprising a polymer such as polyurethane.
- a tapered core wire 26 may extend through the lumen in the hypotube 22, and may comprise stainless steel or a super elastic metal such as a nickel titanium alloy, Nitinol, MP35N, Inconel, etc.
- the distal end of the hypotube 22 in the region of the distal tip 18 may be helically slotted 28 to enhance flexibility.
- the distal end of the core wire 26 may be welded to the distal end of the slotted portion 28 of the hypotube 22 to form an atraumatic weld ball 30.
- the distal portion 16 of the guide wire shaft 12 includes a heat source.
- the heat source comprises a resistive element 32.
- Resistive element 32 may comprise a tungsten or steel alloy that may be formed into a coil and heated by electro-resistive heating.
- Heater coil 32 may be disposed between adjacent turns in the slotted portion 28 of the hypotube 22.
- the resistive heater coil 32 is connected to insultated leads 34 which may be disposed in the lumen of the hypotube 22 around the core wire 26. Leads 34 are connected to coupling 40, which in turn is connected to controller/power supply 50 via lead 60.
- a polymeric outer tube 36 may be disposed about the resistive heater coil 32, and a polymeric inner tube 38 may be provided to support the heater coil 32.
- the polymeric outer tube 36 and/or the polymeric inner tube 38 may be formed of a polymer that changes in stiffness when heated.
- the polymeric outer tube 36 and/or the polymeric inner tube 38 may be formed of a polymer that is relatively stiff at temperatures at or below body temperature (37°C or less) and relatively flexible at temperatures above body temperature.
- a polymer may be selected with a glass transition temperature (T g ) that is above body temperature, such that heating the polymer above T g results in the distal portion 16 of the guide wire 10 becoming relatively more flexible, and cooling the polymer below T g , even when the guide wire 10 is disposed in the patient's body, results in the distal portion 16 of the guide wire 10 becoming relatively more stiff.
- the polymeric outer tube 36 and/or the polymeric inner tube 38 may be formed of a shape memory polymer (SMP) such as a shape memory polyurethane available from Mitsubishi.
- SMPs include polynorbomenes, polycaprolactones and copolymers thereof available from Pnemoscience.
- Some SMPs, such as polynorbomene may change flexibility without changing temperature across T g .
- Such SMPs may be above T g at room temperature or body temperature, and may exhibit SMP characteristics at or near the melt temperature (T m ).
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Endoscopes (AREA)
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US25428 | 1998-02-18 | ||
US10/025,428 US7018346B2 (en) | 2001-12-18 | 2001-12-18 | Guide wire with adjustable flexibility |
PCT/US2002/030771 WO2003051445A1 (en) | 2001-12-18 | 2002-09-26 | Guide wire with adjustable flexibility |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1455881A1 true EP1455881A1 (en) | 2004-09-15 |
EP1455881B1 EP1455881B1 (en) | 2008-12-03 |
Family
ID=21825993
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP02776024A Expired - Lifetime EP1455881B1 (en) | 2001-12-18 | 2002-09-26 | Guide wire with adjustable flexibility |
Country Status (8)
Country | Link |
---|---|
US (2) | US7018346B2 (en) |
EP (1) | EP1455881B1 (en) |
JP (1) | JP4276544B2 (en) |
AT (1) | ATE415999T1 (en) |
AU (1) | AU2002341869A1 (en) |
CA (1) | CA2470598A1 (en) |
DE (1) | DE60230183D1 (en) |
WO (1) | WO2003051445A1 (en) |
Families Citing this family (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7018346B2 (en) * | 2001-12-18 | 2006-03-28 | Scimed Life Systems, Inc. | Guide wire with adjustable flexibility |
EP1765158B1 (en) * | 2004-05-25 | 2017-08-09 | U.S. Endoscopy Group, Inc. | Delivery device |
GB0414222D0 (en) * | 2004-06-24 | 2004-07-28 | Univ Cardiff | pH sensor |
US7989042B2 (en) * | 2004-11-24 | 2011-08-02 | Boston Scientific Scimed, Inc. | Medical devices with highly flexible coated hypotube |
US7828790B2 (en) | 2004-12-03 | 2010-11-09 | Boston Scientific Scimed, Inc. | Selectively flexible catheter and method of use |
US8876772B2 (en) | 2005-11-16 | 2014-11-04 | Boston Scientific Scimed, Inc. | Variable stiffness shaft |
US20070293857A1 (en) * | 2006-06-16 | 2007-12-20 | Wilson-Cook Medical Inc. | Wire Guide Sphincterotome |
US20090118675A1 (en) * | 2007-11-02 | 2009-05-07 | Boston Scientific Scimed, Inc. | Elongate medical device with a shapeable tip |
US7998089B2 (en) * | 2007-11-08 | 2011-08-16 | Radi Medical Systems Ab | Method of making a guide wire based assembly and reusing an energy source |
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US20100168858A1 (en) * | 2008-12-30 | 2010-07-01 | Mitchell Hardenbrook | Expandable interbody implant and method |
US20100228150A1 (en) * | 2009-03-05 | 2010-09-09 | Lake Region Medical, Inc. | Neuro guidewire |
US9295812B2 (en) * | 2011-07-28 | 2016-03-29 | Wright-Ahn Technologies, Llc | Variable stiffness guidewire systems and methods |
US9066828B2 (en) | 2012-06-15 | 2015-06-30 | Trivascular, Inc. | Endovascular delivery system with flexible and torqueable hypotube |
US10835183B2 (en) | 2013-07-01 | 2020-11-17 | Zurich Medical Corporation | Apparatus and method for intravascular measurements |
JP5976983B1 (en) | 2013-07-01 | 2016-08-24 | ズーリック・メディカル・コーポレイションZurich Medical Corporation | Apparatus and method for intravascular measurement |
CN106573125B (en) * | 2014-06-18 | 2020-05-22 | 皇家飞利浦有限公司 | Elongated interventional device with variable stiffness |
WO2017147041A1 (en) * | 2016-02-22 | 2017-08-31 | Arizona Board Of Regents On Behalf Of Arizona State University | Adjustable guidewire |
US11278701B2 (en) | 2016-10-13 | 2022-03-22 | Lake Region Manufacturing, Inc. | Apparatus including multiple joined hypotubes and method of making same |
US10953204B2 (en) | 2017-01-09 | 2021-03-23 | Boston Scientific Scimed, Inc. | Guidewire with tactile feel |
CN111163831A (en) * | 2017-09-14 | 2020-05-15 | W.L.戈尔及同仁股份有限公司 | Variable stiffness guidewire |
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- 2002-09-26 EP EP02776024A patent/EP1455881B1/en not_active Expired - Lifetime
- 2002-09-26 DE DE60230183T patent/DE60230183D1/en not_active Expired - Lifetime
- 2002-09-26 WO PCT/US2002/030771 patent/WO2003051445A1/en active Application Filing
- 2002-09-26 JP JP2003552374A patent/JP4276544B2/en not_active Expired - Lifetime
- 2002-09-26 AT AT02776024T patent/ATE415999T1/en not_active IP Right Cessation
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See references of WO03051445A1 * |
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DE60230183D1 (en) | 2009-01-15 |
US7018346B2 (en) | 2006-03-28 |
WO2003051445A1 (en) | 2003-06-26 |
AU2002341869A1 (en) | 2003-06-30 |
ATE415999T1 (en) | 2008-12-15 |
US20060127561A1 (en) | 2006-06-15 |
US20030114776A1 (en) | 2003-06-19 |
JP4276544B2 (en) | 2009-06-10 |
EP1455881B1 (en) | 2008-12-03 |
US7918806B2 (en) | 2011-04-05 |
JP2005528931A (en) | 2005-09-29 |
CA2470598A1 (en) | 2003-06-26 |
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